PR3-AAV Resilient Remission or PRRR

Exclusion Criteria

• •Diagnosis with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) as defined by the Chapel Hill Consensus Conference.
• •Positive serum assays for ANCA directed against myeloperoxidase (MPO-ANCA)
• •Non-severe AAV, defined as disease that does not justify treatment with both B cell depletion and a four-month glucocorticoid taper.
• •Any of the co-morbidities:
• •* Allergies: a history of severe allergic reactions to human or chimeric monoclonal antibodies or murine protein.
• •* Infection (systemic): an active systemic infection at screening visit
• •* Infection (deep space): have been diagnosed as having a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by empyema or lung abscesses, within 6 months prior to the screening visit
• •* Infection (blood borne): active hepatitis B or active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C
• •* Infection (history): History of recurrent significant infection or history of recurrent bacterial infections
• •* Liver disease: acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial.
• •* Renal disease: a history of documented anti-glomerular basement membrane disease (anti-GBM disease).
• •* Malignancy: Active or history of malignancy in the last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment.
• •* Active COVID-19 infection.
• •* Uncontrolled disease: evidence of glucocorticoid dependent disease (such as asthma, COPD, psoriasis or IBD, etc.) requiring consistently greater than 10 mg of prednisone for disease control which might affect endpoint assessment or,
• •* Other uncontrolled diseases, including any uncontrolled psychiatric disorders, drug and alcohol abuse, that could interfere with participation in the trial according to the protocol.
• •Diagnosis of human anti-chimeric antibodies (HACA) formation.
• •Subjects who are premenopausal and are:
• •* Pregnant on the basis of a serum pregnancy test,
• •* Breastfeeding, or
• •* Do not agree to use effective method(s) of contraception
• •Use of prohibited medications: They have used any of the prohibited medication listed in Section 5.9.1.
• •Plasma exchange: They have been treated with plasma exchange within the 3 months preceding the screening visit.
• •History of intolerance to rituximab or other chimeric monoclonal antibodies (e.g., infliximab).
• •Recent vaccination: They have had a live vaccine fewer than 4 weeks (28 days) before or during randomization (vaccination with live vaccine through the end of study participation is contraindicated).
• •Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)
• •* Bone marrow suppression as evidenced by a total white count \< 4 x10 /l, hemoglobin \< 7 gm/dl or platelet count \< 100,000/μl
• •* Aspartate aminotransferase or alanine aminotransferase or amylase \> 2.5 times the upper limit of normal, unless attributed to vasculitis